MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGM; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number	CMV IGM ELECSYS E2G
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with the elecsys cmv igm immunoassay on a cobas 8000 e 801 module (serial number (b)(4)).Refer to the attachment for all patient data.The data highlighted in red is questionable and was reported outside of the laboratory.The result did not agree with results obtained with competitor methods.
Additional Manufacturer Narrative
The patient sample was requested for investigation.
Additional Manufacturer Narrative
The three samples from the patient were provided for investigation.The results obtained by the customer could not be reproduced.The cmv igm results were borderline for all three samples.The cmv igg results were reactive or borderline.A general reagent issue can be excluded.
Additional Manufacturer Narrative
The results of the customer could not be completely confirmed, the elecsys cmv igm assay was borderline reactive for the first sample and the elecsys cmv igg assay showed reactivity for the second sample.Primary infection in the early phase is indicated in this case due to the presence of increasing igg titers and borderline reactivity in the elecsys cmv igm assay.However, the detection of seroconversion was less prominent for elecsys assays compared to competitor assays.Additional assessment with the recomline cmv igm and igg assay (mikrogen) revealed reactivity for both igm and igg for all of the samples.The recomline blot results are in accordance with the diasorin results.
Additional Manufacturer Narrative
The investigation determined: the elecsys cmv igm reagent performs within specifications.

• Brand Name: ELECSYS CMV IGM
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16117578
• Report Number: 1823260-2023-00080
• Device Sequence Number: 17845470
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: CMV IGM ELECSYS E2G
• Device Lot Number: 59800401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/13/2023; 02/21/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/27/2023; 02/17/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female